Real Time Pain Relief Cream

Description

No specific details regarding the Description section for SPL code 34089-3 are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various conditions, including arthritis, simple backache, muscle strains, sprains, bruises, and cramps.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children over 2 years of age, the recommended dosage involves applying a generous amount of the product to the affected area. The application should be followed by a gentle massage into the painful area until the product is thoroughly absorbed into the skin. This process may be repeated as necessary, with a maximum frequency of four times daily.

For children aged 2 years or younger, it is advised to consult a physician before use.

Contraindications

The product is contraindicated for application to wounds or damaged skin due to the potential for irritation or adverse reactions. Additionally, it should not be used with tight bandaging, as this may compromise circulation and lead to further complications.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to adhere strictly to this guideline to prevent potential adverse effects associated with inappropriate use.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients or caregivers are advised to contact a Poison Control Center or seek emergency medical help without delay.

Healthcare providers should instruct patients to discontinue use and consult their physician under the following circumstances: if the condition worsens, if symptoms persist beyond 7 days, if symptoms resolve and then recur within a few days, if there is any presence of redness, or if irritation develops. Monitoring for these signs is essential to ensure patient safety and effective management of their condition.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days. Additionally, if redness is present or irritation develops, medical advice should be sought.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Real Time Pain Relief Cream (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients over 2 years of age may apply the medication generously to the affected area, massaging it into the skin until thoroughly absorbed. This application may be repeated as necessary, but should not exceed four times daily. For pediatric patients 2 years of age or younger, it is advised to consult a doctor before use.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Dosage adjustments may be necessary for patients with reduced renal function. It is important to monitor renal function tests regularly in patients with known kidney problems. A reduced dose should be considered for patients with a creatinine clearance of less than 30 mL/min.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to instruct patients to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Patients should also be informed to stop using the product and seek medical advice if symptoms clear up and then recur within a few days, or if any redness is observed.

Additionally, healthcare providers should emphasize the importance of using the product only as directed. Patients should be cautioned to avoid contact with the eyes or mucous membranes during use. They should also be advised not to apply the product to wounds or damaged skin, and to refrain from bandaging the area tightly after application.

Storage and Handling

The product is supplied in packaging that ensures its integrity and quality. It should be stored at room temperature, specifically within the range of 20°C to 25°C (68°F to 77°F). It is essential to protect the product from light exposure to maintain its efficacy. Freezing the product is strictly prohibited, as it may compromise its stability. Once opened, the product must be discarded to ensure safety and effectiveness.

Additional Clinical Information

The product is administered topically. For adults and children over 2 years of age, it should be applied generously to the affected area and massaged into the skin until fully absorbed. This application can be repeated as necessary, but should not exceed four times daily. For children aged 2 years or younger, it is advised to consult a doctor before use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Real Time Pain Relief Cream, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)